FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
111049–111072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1993
CIBA CORNING ACS ESTRADIOL IMMUNOASSAY
K932715 · CHP
Ciba Corning Diagnostics Corp.
Chemistry · 182d
Cleared Dec 03, 1993
CIBA CORNING ACS FREE T3 IMMUNOASSAY
K932747 · CDP
Ciba Corning Diagnostics Corp.
Chemistry · 178d
Cleared Dec 03, 1993
ELECTROMEDICS BLOOD HEAT EXCHANGER
K934355 · DTR
Electromedics, Inc.
Cardiovascular · 87d
Cleared Dec 03, 1993
LACTOFERRIN MICROASSAY SYSTEM
K934473 · DEG
Touch Scientific, Inc.
Immunology · 80d
Cleared Dec 03, 1993
R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
K934660 · DSH
R & D Batteries, Inc.
Cardiovascular · 66d
Cleared Dec 03, 1993
R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470
K934747 · JPA
R & D Batteries, Inc.
Hematology · 60d
Cleared Dec 03, 1993
COCAINE METABOLITE EIA ASSAY MODIFICATION
K935016 · DIO
Diagnostic Reagents, Inc.
Chemistry · 46d
Cleared Dec 02, 1993
ENDOWASH
K915620 · FEB
Novar Medical Industries
General Hospital · 738d
Cleared Dec 02, 1993
FRESENIUS POLYSULFONE DIALYZERS
K921134 · KDI
Fresenius USA, Inc.
Gastroenterology & Urology · 632d
Cleared Dec 02, 1993
STREP A NEGATIVE CONTROL
K924461 · GTZ
Pacific Biotech, Inc.
Microbiology · 456d
Cleared Dec 02, 1993
OE 1.5 SI
K925858 · LNH
Otsuka Electronics
Radiology · 380d
Cleared Dec 02, 1993
CARAPACE STERILE COTTON BALLS
K931626 · FRL
Carapace, Inc.
General Hospital · 244d
Cleared Dec 02, 1993
PARAPREP
K931849 · LKS
Medastat Scientific Corp.
Microbiology · 233d
Cleared Dec 02, 1993
BIOSIL MEDICAL GRADE SILICONE SHEETING
K932176 · KHJ
Bioplexus Corp.
Ear, Nose, Throat · 211d
Cleared Dec 02, 1993
NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
K932406 · JNO
Nuclear Diagnostics, Inc.
Chemistry · 203d
Cleared Dec 02, 1993
B-HCG HUMAN SERUM CONTROLS
K932479 · JJX
Pyramid Biological Corp.
Chemistry · 192d
Cleared Dec 02, 1993
RITTER MODEL 158 AND 159 EXAM LIGHTS
K932719 · KZF
Midmark Corp.
General Hospital · 181d
Cleared Dec 02, 1993
LAERDAL(TM) POCKET MASK, MODIFICATION
K933048 · KGB
Laerdal Medical Corp.
Anesthesiology · 205d
Cleared Dec 02, 1993
KING SYSTEMS HME
K934441 · BYD
King Systems Corp.
Anesthesiology · 83d
Cleared Dec 02, 1993
ENDOSCOPIC VIDEO SYSTEM AND ENDOSCOPIC VIDEO CAMERA
K934623 · FET
Endomedix
Gastroenterology & Urology · 66d
Cleared Dec 02, 1993
REAGENTS FOR COBAS ISE MODULE
K934701 · JIX
Alko Diagnostic Corp.
Chemistry · 63d
Cleared Dec 02, 1993
HCG PREGNANCY ONE STEP TEST STRIP
K934830 · LCX
Tcpi, Inc.
Chemistry · 55d
Cleared Dec 02, 1993
STABILTRACH
K935171 · CBH
B&B Medical Technologies, Inc.
Anesthesiology · 37d
Cleared Dec 01, 1993
MIC LOW PROFILE GASTROSTOMY TUBE
K922667 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 597d